Metabiomics Colon Cancer Clinical Research Study | NCT02151123

Studies
Metabiomics Colon Cancer Clinical Research Study

NCT02151123

Sponsor

Metabiomics Corp

Status

Withdrawn

Last Update Posted

Sep 26, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Colonic Neoplasms

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding not secured

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Mar 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

May 27, 2014

First Submission Date that Met QC Criteria

May 27, 2014

First Posted Date

May 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.

Detailed Description

The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnosed colon cancer patients		Patients undergoing colectomy for colonic adenocarcinoma.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
False negative rate of test for colon cancer	The False Negative Rate is calculated as (100*False Negative) /(True Positive + False Negative).	immediately post surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy
Male or female,
Age: 18-95 years,
Able to comprehend, sign, and date the written informed consent form (ICF),
Able to give informed consent in English
Women and minorities will be included.

Exclusion Criteria:

History of Inflammatory Bowel Disease
Antibiotics within 2 weeks of sample collection.
Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection
Any radiation therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Vogel, MD	University of Colorado School of Medicine Anschutz Medical Campus	Principal Investigator
Christopher Lieu, MD	University of Colorado School of Medicine Anschutz Medical Campus	Principal Investigator
Patrick Gillevet, PhD	George Mason University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado School of Medicine Anschutz Medical Campus		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided